Regulatory Affairs Manager - Biosimilars

Amgen Inc.

3.6

(9)

United States (Remote)

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-190729

    Position summary

    s; may act as product lead for one or more products.

    • Provides CMC regulatory oversight in the development, communication, and implementation of global regulatory strategies

    • Executes regulatory strategy with respect to preparation of submissions including analytical similairty packages and quality sections for briefing books, CTAs, MAs, annual reports, manufacturing amendments, and other documents.

    • Supports cross-functional teams in development and submission of Quality/Operations/CMC regulatory documents, including responses to questions from regulatory authorities

    • Supports CMC-related agency interactions

    • Represents RA CMC at relevant team meetings

    • Complies with Amgen Regulatory CMC processes

    • Identifies and supports changes to process and strategy in response to internal Amgen initiatives and changes in external regulatory policy and guidance

    • Collaborates with other Regulatory Department functions on biosimilar issues, (eg, CMC, Regulatory Operations, Devices)

    Basic Qualifications

    Doctorate degree

    OR

    Master's degree and 3 years of regulatory, CMC, manufacturing, testing or process/product development experience

    OR

    Bachelor's degree and 5 years of regulatory, CMC, manufacturing, testing or process/product development experience

    OR

    Associate's degree and 10 years of regulatory, CMC, manufacturing, testing or process/product development experience

    OR

    High school diploma / GED and 12 years of regulatory, CMC, manufacturing, testing or process/product development experience

    Preferred Qualifications

    Planning and organizing abilities

    Managing multiple activities

    Problem solving abilities

    Setting priorities

    Team work

    Multi-disciplinary nature

    Dealing with ambiguity

    Action oriented

    Flexibility with day-to-day requirements

    Conflict management

    Strong oral and written communication skills

    Excellent interpersonal and organizational skills

    Ability to provide support for team members

    Thrive

    Some of the vast rewards of working here

    As we work to develop treatments that take care of others, so we work to care for our teammates' professional and personal growth and well-being.

    • Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey

    • A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

    • Generous Total Rewards Plan-comprising health, finance and wealth, work/life balance, and career benefits-with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

    Apply now

    for a career that defies imagination

    Objects in your future are closer than they appear. Join us.

    careers.amgen.com

    Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position

    Equal Opportunity Statement

    Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

    We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

    Salary Range
    104,616.00 USD - 134,871.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging